Heart MurmursFeMurNCT04306991
Modifications of Heart Murmurs and Cardiac Output During Fever
A study testing Auscultation using an electronic stethoscope (EKO CORE 4) in people with Heart Murmurs and Fever, run by University Hospital, Angers.
Trial summary
The combination of fever and auscultation of a heart murmur suggests the diagnosis of endocarditis. However, fever itself increases cardiac output and could therefore modify heart sounds. The aim of the FeMur study is to measure the modification of heart sounds during fever. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Murmurs, Fever
- What is being tested?
- Auscultation using an electronic stethoscope (EKO CORE 4)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hospitalized febrile patients (body temperature > 38.5°C)
- Aged 18 or older
- Agreement to participate to the study
Who cannot join
- Patients treated with beta-blockers, verapamil, or diltiazem
- Patients with atrial fibrillation
- Pregnancy or breastfeeding
- Patients with severe psychiatric disorder
- Patients with diminished heart sounds
Trial locations and contacts
No sites are listed yet.
About this study
The combination of fever and auscultation of a heart murmur suggests the diagnosis of endocarditis. However, fever itself increases cardiac output and could therefore modify heart sounds. The aim of the FeMur study is to measure the modification of heart sounds during fever.
Heart sounds of 15 hospitalized febrile patients with a heart murmur will be recorded using an electronic stethoscope before and after resolution of fever. The records will be analyzed using a computerized application in order to quantify the intensity of heart murmurs.
Read the detailed description
Fever is an frequently observed during acute illnesses, particularly infectious diseases. The hemodynamic consequences of fever have been extensively studied. Fever leads to an acceleration of heart rate (approximately 8.5 bpm per degree celsius) and to a moderate drop in blood pressure. Cardiac output increases in the context of heat stress as a result of complex physiological adaptations, including heart rate and systolic function increase while preload and after load decrease.
However, there are no studies on the specific consequences of fever on heart sounds. The question is important since auscultation of a heart murmur in a febrile patient suggests the diagnosis of endocarditis. In endocarditis, the heart murmur, which is present in 85% of cases, is due to the mutilation of heart valves, which requires urgent diagnostic and therapeutic management. Suspicion of endocarditis requires emergency cardiac ultrasonography. However, the proportion of patients with actual endocarditis among patients with heart murmur and fever is low. This could arise from the fact that fever itself may increase or trigger a heart murmur. Indeed, any increase in cardiac output may generate audible turbulence when blood is pumped across a heart valve.
Functional or inorganic murmurs are murmurs triggered by changes in cardiac output or blood viscosity, as opposed to organic murmurs reflecting an anatomical abnormality in the heart. Certain characteristics of the murmur and the context of occurrence can guide the clinical toward one of these two situations, but distinguishing functional from organic murmurs is most often difficult.
The impact of fever on cardiac murmurs has not been experimentally demonstrated. This is the aim of the FeMur study.
For this purpose, heart sounds of 15 patients will be recorded during a febrile ilness and after resolution of fever using an electronic stethoscope and analyzed using a computer application. The average intensity of heart murmurs will be compared between the two periods in order to determine the impact of fever.
- Conditions
- Heart Murmurs, Fever
- Being tested
- Auscultation using an electronic stethoscope (EKO CORE 4)
- Medical subject headings
- Heart Murmurs, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auscultation using an electronic stethoscope (EKO CORE 4)Device
- Auscultation using an electronic stethoscope (EKO CORE 4). Record of at least 3 cardiac cycles.
- Measurement of cardiac output using echocardiography.
| Study group | Role | What they receive |
|---|---|---|
| Fever | Experimental | Auscultation using an electronic stethoscope Measurement of cardiac output using echocardiography Receives: Device: Auscultation using an electronic stethoscope (EKO CORE 4) |
| Apyrexia | Experimental | Auscultation using an electronic stethoscope Measurement of cardiac output using echocardiography Receives: Device: Auscultation using an electronic stethoscope (EKO CORE 4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Murmur intensity
Proportion of patients with a modification of heart sounds (computerized comparison of murmur intensity during fever and during apyrexia)
Measured: up to 7 days
Secondary outcomes (1)
Cardiac output (echocardiography)
Comparison of cardiac output measured using echocardiography during fever and after resolution of fever (apyrexia)
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study startMar 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart MurmursStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Each patient will be auscultated twice: * during a febrile episode (body temperature \>38.5°C) * after resolution of fever (body temperature \< 37.5°C)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Vincent Dubee, MD, PhD, Study director, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306991
- Sponsor's protocol ID
- 49RC19_0202
- Acronym
- FeMur
- Status last verified
- Dec 2019
- First submitted
- 17 Jan 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifications of Heart Murmurs and Cardiac Output During Fever
- ClinicalTrials.gov ID
- NCT04306991
- Acronym / sponsor ID
- FeMur / 49RC19_0202
- Conditions
- Heart Murmurs, Fever
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Mar 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The combination of fever and auscultation of a heart murmur suggests the diagnosis of endocarditis. However, fever itself increases cardiac output and could therefore modify heart sounds. The aim of the FeMur study is to measure the modification of heart sounds during fever.
Heart sounds of 15 hospitalized febrile patients with a heart murmur will be recorded using an electronic stethoscope before and after resolution of fever. The records will be analyzed using a computerized application in order to quantify the intensity of heart murmurs.
Detailed description
Fever is an frequently observed during acute illnesses, particularly infectious diseases. The hemodynamic consequences of fever have been extensively studied. Fever leads to an acceleration of heart rate (approximately 8.5 bpm per degree celsius) and to a moderate drop in blood pressure. Cardiac output increases in the context of heat stress as a result of complex physiological adaptations, including heart rate and systolic function increase while preload and after load decrease.
However, there are no studies on the specific consequences of fever on heart sounds. The question is important since auscultation of a heart murmur in a febrile patient suggests the diagnosis of endocarditis. In endocarditis, the heart murmur, which is present in 85% of cases, is due to the mutilation of heart valves, which requires urgent diagnostic and therapeutic management. Suspicion of endocarditis requires emergency cardiac ultrasonography. However, the proportion of patients with actual endocarditis among patients with heart murmur and fever is low. This could arise from the fact that fever itself may increase or trigger a heart murmur. Indeed, any increase in cardiac output may generate audible turbulence when blood is pumped across a heart valve.
Functional or inorganic murmurs are murmurs triggered by changes in cardiac output or blood viscosity, as opposed to organic murmurs reflecting an anatomical abnormality in the heart. Certain characteristics of the murmur and the context of occurrence can guide the clinical toward one of these two situations, but distinguishing functional from organic murmurs is most often difficult.
The impact of fever on cardiac murmurs has not been experimentally demonstrated. This is the aim of the FeMur study.
For this purpose, heart sounds of 15 patients will be recorded during a febrile ilness and after resolution of fever using an electronic stethoscope and analyzed using a computer application. The average intensity of heart murmurs will be compared between the two periods in order to determine the impact of fever.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each patient will be auscultated twice: * during a febrile episode (body temperature >38.5°C) * after resolution of fever (body temperature < 37.5°C)
| Arm | Type | Receives |
|---|---|---|
| Fever | Experimental | Device: Auscultation using an electronic stethoscope (EKO CORE 4)Auscultation using an electronic stethoscope Measurement of cardiac output using echocardiography |
| Apyrexia | Experimental | Device: Auscultation using an electronic stethoscope (EKO CORE 4)Auscultation using an electronic stethoscope Measurement of cardiac output using echocardiography |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalized febrile patients (body temperature > 38.5°C)
- Aged 18 or older
- Agreement to participate to the study
Key exclusion criteria (5 listed)
- Patients treated with beta-blockers, verapamil, or diltiazem
- Patients with atrial fibrillation
- Pregnancy or breastfeeding
- Patients with severe psychiatric disorder
- Patients with diminished heart sounds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auscultation using an electronic stethoscope (EKO CORE 4)* Auscultation using an electronic stethoscope (EKO CORE 4). Record of at least 3 cardiac cycles. * Measurement of cardiac output using echocardiography. | Device | Apyrexia, Fever |
Primary outcome
Murmur intensity
Time frame: up to 7 days
Proportion of patients with a modification of heart sounds (computerized comparison of murmur intensity during fever and during apyrexia)
1 secondary outcome
Cardiac output (echocardiography)
Time frame: up to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Dubee, MD, PhD study director
University Hospital, Angers
Questions about this trial
What is this clinical trial studying?
A study testing Auscultation using an electronic stethoscope (EKO CORE 4) in people with Heart Murmurs and Fever, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent Dubee, MD, PhD (0033665807022, vincent.dubee@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Murmur intensity (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.